Role of NLRP3 Inflammasone and Hypoxia in the Severity of Osteoporosis in Patients With Bronchiectasis

• Conditions: Bronchiectasis Adult; Osteoporosis, Osteopenia
• Interventions: Other: Inflammasone

• Registration Number: NCT03467035
• Lead Sponsor: Chun-Hua Wang, MD

Brief Summary

The objectives of this research grant are to determine the association of hypoxia with the severity of osteoporosis in the patients with bronchiectasis and whether the mechanism of inflammation is triggered by inflammasones, which makes it more prone to osteoporosis in patients with bronchiectasis.

Detailed Description

80 patients with proven bronchiectasis, diagnosed by high-resolution computed tomography (HRCT), will be recruited from our outpatient clinic of Chang Gung Memorial Hospital with written informed consent. Inclusion criteria are: daily sputum \> 10 ml; absence of asthma or other unstable systemic diseases; and "steady-state" bronchiectasis (\< 10% alteration of 24 h sputum volume, FEV1, and FVC, and in the absence of deterioration in respiratory symptoms at baseline visits). Exclusion criteria include: unreliable clinic attendance; regular user of inhaled or oral corticosteroids; history of lung resection and known asthma defined according to American Thoracic Society guidelines.

The lung function and desaturation will be assessed by six-minute walking tests and the severity of disease will be evaluated by HRCT scores. Peripheral blood sample (40ml/person) is performed to analyze the bone turnover markers and the level of Hif in PBMC.

Study Timeline

• Study Start: 2017-12-21
• Status Verified: 2018-03
• Study First Submitted: 2018-03-07
• Study First Submitted QC: 2018-03-14
• Last Update Submitted: 2018-03-14
• Study First Posted: 2018-03-15
• Last Update Posted: 2018-03-15
• Primary Completion: 2018-12-31
• Study Completion: 2019-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

1. willing to sign a written consent form
2. Male and female subjects with bronchiectasis diagnosed by high-resolution computed tomography
3. willing to accept 6-minute exercise pulmonary function test and blood draw
4. Men and women over the age of 20
5. Has undergone chest computed tomography and bone density examination in the recent five years

Exclusion Criteria

1. pregnant women or lactating women
2. asthma, lung resection history before the screening period
3. active Tuberculosis infection
4. Have received oral steroid treatment within 30 days
5. current acute attack or clinical symptoms instability of bronchiectasis

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
desaturation	Inflammasone	ΔSpO2 \>10% or lowest SpO2\<90 during baseline six minute walk test Check serum level of inflammasone, such as IL-1beta, TGF-beta TRT-PCR for PBMC
non-desaturation	Inflammasone	ΔSpO2 \<10% and lowest SpO2\>90 during baseline six minute walk test Check serum level of inflammasone, such as IL-1beta, TGF-beta TRT-PCR for PBMC

Primary Outcome Measures

Name	Time	Method
six minute walk test	6 months	six minute walk test distance

Trial Locations

Locations (1)

Chang Gung Memorial Hospital; 🇨🇳 Taipei, Taiwan